Dedo Suction Cannula
FDA 510(k) K854005 · Dedo Manufacturer, Inc.
510(k) numberK854005
Submission
- Device name
- Dedo Suction Cannula
- Applicant
- Dedo Manufacturer, Inc.
West Palm Beach, FL, US - Received
- September 30, 1985
- Decision date
- December 6, 1985
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEA – Cannula, Surgical, General & Plastic Surgery
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4800
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003965 | MRI Safe InstrumentsGEA · Traditional | Aesculap, Inc. | 03/16/2001SE |
| K982472 | Genicon TrocarGEA · Traditional | Genicon, LC | 02/04/1999SE |
| K954599 | Conmed Trogard Electronic Trocar SystemGEA · Traditional | Conmedcorp | 11/27/1995SE |
| K922460 | Origin Secondary Cannula and TrocarGEA · Traditional | Origin Medsystems, Inc. | 09/16/1992SE |
| K920110 | Endopath Disposable Thoracic Trocar SleeveGEA · Traditional | ETHICON, Inc. | 04/02/1992SE |
| K911262 | Disposable Specimen Bag W/Cannula and IntroducerGEA · Traditional | ETHICON, Inc. | 06/20/1991SE |
| K904881 | Disposable Yankauer Suction TubeGEA · Traditional | Pilling Medical S.A. | 03/06/1991SE |
| K903416 | Cannula, SurgicalGEA · Traditional | Advantage Diagnostics Corp. | 11/23/1990SE |
| K904218 | Suction SystemGEA · Traditional | Axiom Medical, Inc. | 10/31/1990SE |
| K901718 | Klein Lamprey-Cannula(Tm)GEA · Traditional | Jeff Klein Surgical, Inc. | 05/24/1990SE |
Questions and answers
When was Dedo Suction Cannula cleared by the FDA?
Dedo Suction Cannula (K854005) received a 510(k) decision of Substantially Equivalent for Some Indications on December 6, 1985, 67 days after the submission was received.
What is the product code of K854005?
The FDA product code is GEA – Cannula, Surgical, General & Plastic Surgery, a Class I (low risk) device regulated under 21 CFR 878.4800.